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Federal Trade Commission
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078592

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NDA 078592 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Wockhardt Bio Ag, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in eighteen NDAs. It is available from thirty suppliers. Additional details are available on the CARBAMAZEPINE profile page.

The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 078592
Tradename:CARBAMAZEPINE
Applicant:Teva Pharms
Ingredient:carbamazepine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592 ANDA Teva Pharmaceuticals USA Inc 0093-5512 N 0093-5512-89
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592 ANDA Teva Pharmaceuticals USA Inc 0093-5513 N 0093-5513-89

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Sep 20, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Sep 20, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Sep 20, 2012TE:ABRLD:No

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